Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 4:12 AM
Ignite Modification Date: 2025-12-26 @ 3:10 AM
NCT ID: NCT04411420
Description: Adverse Events were collected on survey participants only. A non-systematic method was implemented. Adverse events were collected via unsolicited participant self-report during follow-up study surveys. Study staff attempted to verify reported adverse events via medical record review. All hospitalizations were considered serious and Emergency Department visits were considered important medical events. All events were assessed for study relatedness. All events were reviewed by the Durham VA IRB.
Frequency Threshold: 0
Time Frame: Up to 12 months
Study: NCT04411420
Study Brief: Improving Veteran Access to Integrated Management of Back Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Integrated Care Pathway The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA. 1 None 18 516 12 516 View
Coordinated Care Management Pathway The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain. 2 None 30 480 20 480 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Important Medical Events SYSTEMATIC_ASSESSMENT General disorders None View